Clinical Trial Criteria

Clinical Trial Criteria

Office of Sponsored Programs Guidance Clinical Trial Criteria

Clinical Trial Criteria

The following criteria define standard clinical trials and will be used by OSP in their determination:

  1. Human subjects are used.
  2. A budget identifies anticipated pricing and support costs; however, spending of the award by budget category is discretionary.
  3. There is limited financial accountability to the sponsor and there is not requirement to return funds to the sponsor.
  4. The sponsor agrees to indemnify UAB; retains invention rights in accordance with UAB policy; agrees to not use UAB’s name without consent; and does not restrict UAB’s right to publish.
  5. The sponsor provides a protocol that has been tested and developed for the drug, device or treatment regimen in accord with FDA regulations, has obtained FDA approval to proceed to clinical trial, and has been issued an investigational drug or device number.
  6. Uniform pricing is used, based upon the number of patients enrolled, number of trials completed, number of exams, etc.
  7. Deliverables are defined as completed case report forms or the equivalent.

In addressing the treatment of clinical trials, UAB recognizes the following:

  1. Consistency: The standard clinical trial agreement is available to all sponsors, including federal agencies, as long as the trial complies with the seven criteria listed above. Should any clinical trial proposed not meet these criteria, it will be classified as a standard grant or contract and the appropriate full F&A rate based on modified total direct cost will apply.
  2. Conflict of Interest: The standard UAB conflict of interest policies apply.
  3. Unrelated business income status: As these activities take on the characteristics of a business agreement, rather than a grant of contract, the relatedness of these activities to the university mission needs to be reviewed
  4. Costs: All costs associated with the conduct of the clinical trial are to be charged to the specific clinical trial account. Billing of sponsors’ experimental costs for a drug or device to third party medical insurance is prohibited, unless there is prior FDA approval. The clinical trial indirect cost will be recovered upon each deposit and will not be dependent upon expenditures. Any residuals remaining at the completion of the trial will be recognized as non-operating revenue and deposited in a miscellaneous unrestricted account. The end date of the trial is determined by contract, modified by sponsor (when required), or by report of the principal investigator to OSP.
  5. Effort Reporting: Clinical trial activity will be treated as a single activity and reported as per UAB’s Effort Reporting Policy.